Protocol Review and Monitoring

方案审查和监控

• 批准号: 8077350
• 负责人: STEVEN P STRATTON
• 金额: $ 7.92万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8077350
• 关键词: Arizona; Authorization documentation; Basic Science; Behavioral; Cancer Center; Caring; Chairperson; Clinical; Clinical Research; Consent; Diagnostic; Discipline; Ensure; Faculty; Grant; Gynecologic Oncology; Hematology; Laboratories; Malignant Neoplasms; Medical; Monitor; Nature; Patients; Pediatric Hematology/Oncology; Peer Review; Performance; Protocols documentation; Radiation Oncology; Records; Research; Research Ethics Committees; Research Personnel; Resource Sharing; Review Committee; Sampling; Services; Surgical Oncology; System; Therapeutic; Translational Research; Treatment Protocols; United States National Institutes of Health; Writing; base; cancer chemoprevention; cancer therapy; design; member; oncology; population based; research study

9.2 Protocol Review and Monitoring System (PRMS) The Protocol Review and Monitoring System at the Arizona Cancer Center facilitates the our Scientific Review Committee (SRC), which is staffed with appropriate faculty and scientific representation in all disiciplines, to include but not be limited to medical hematology/oncology, surgical oncology, gynecologic oncology, radiafion oncology, pediatric hematology/oncology. Other medical subspecialities, cancer chemoprevention, and, translationals studies with clinical and basic science collaborators are also covered. The primary responsibilities of the AZCC SRC include the following: ¿ Review of all new hypothesis-generated interventional protocols of diagnostic or therapeutic nature as well as longitudinal population-based studies involving patients, patient samples, or patient records conducted by AZCC members to ensure the highest scientific quality of clinical research in advance of IRB submission. ¿ Review ongoing progress of protocols conducted by AZCC members to maximize scientific validity, assure timely and effective performance. - ¿ Evaluate the merit of eligible protocols for utilization of AZCC shared resources/services based upon objective scientific review. ¿ Promote unified standards for protocol implementation and translational research among AZCC investigators of various disciplines involved in cancer treatment and care. Regardless of the protocol type, no clinical research study eligible for SRC review can be submitted to the institutional IRB until SRC approval is granted. SRC actions and approval will accompany IRB submissions. In exceptional circumstances, concurrent IRB review may be allowed with written permission from the SRC Chairman.

9.2协议审查和监测系统(PRMS) 亚利桑那州癌症中心的方案审查和监测系统促进了我们的科学审查 委员会(SRC)，其工作人员配备了适当的教员和所有学科的科学代表，以 包括但不限于内科血液学/肿瘤学、外科肿瘤学、妇科肿瘤学、放射学 肿瘤学、儿童血液学/肿瘤学。其他医学子专业，癌症化学预防，以及， 与临床和基础科学合作者的翻译研究也包括在内。 AZCC SRC的主要职责包括： ？审查所有新的假设产生的诊断或治疗性质的介入方案，如 以及涉及患者、患者样本或患者记录的基于人群的纵向研究 由AZCC成员进行，以确保提前进行最高科学质量的临床研究 IRB意见书。 ？审查AZCC成员为最大限度地提高科学有效性而进行的议定书的持续进展， 确保及时有效的工作表现。 -？根据以下各项，评估利用AZCC共享资源/服务的合格协议的优点 客观的科学综述。 推动AZCC之间的协议实施和翻译研究的统一标准 参与癌症治疗和护理的不同学科的研究人员。 无论方案类型如何，任何符合SRC审查资格的临床研究研究都不能提交给 机构IRB，直到SRC批准为止。SRC的行动和批准将伴随着IRB提交。在……里面 在特殊情况下，可在获得SRC书面许可的情况下允许同时进行IRB审查 主席。